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FDA 510(k)

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)

K-Number: K210935 · 2022-08-31

ApplicantI.T.S. GmbH
Decision Date2022-08-31
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. GmbH. It received FDA 510(k) clearance on 2022-08-31 under 510(k) number K210935. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)?

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is a medical device that received FDA 510(k) clearance on 2022-08-31. The listed applicant is I.T.S. GmbH. The 510(k) number is K210935.

When did I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) receive FDA 510(k) clearance?

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) received FDA 510(k) clearance on 2022-08-31, under 510(k) number K210935.

Who is the listed applicant for I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)?

The FDA 510(k) record lists I.T.S. GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)?

The FDA product code for I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is HRS.

Other records listing I.T.S. GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (LK260054I.T.S. PRS Phoenix IIK233134I.T.S. INS Proximal Femur Nail

Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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